Bioretec L T D

FDA Filings

This page includes the latest FDA filings for Bioretec L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005536892
FEI Number3005536892
NameMichael van der Woude
Owner & OperatorBioretec Ltd.
Contact AddressHermiankatu 22
Tampere FI-NOTA FI-33720 FI
Official Correspondent
  • Mari S Ruotsalainen
  • 358-20-7789500-9514
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Michael van der Woude [Bioretec Ltd.]
ActivaPin2014-02-20
Michael van der Woude [Bioretec Ltd.]
ActivaNail Conical2014-02-20
BIORETEC LTD.
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)2014-01-22
Michael van der Woude [Bioretec Ltd.]
TorqLoc Interference2013-09-12
Michael van der Woude [Bioretec Ltd.]
ActivaScrew Interference2013-09-12
BIORETEC LTD
BIORETEC ACTIVASCREW INTERFERENCE2013-08-28
Michael van der Woude [Bioretec Ltd.]
ActivaScrew2008-06-26
Michael van der Woude [Bioretec Ltd.]
ActivaScrew Cannulated2008-06-26
Michael van der Woude [Bioretec Ltd.]
ActivaPinTM2008-06-26
Michael van der Woude [Bioretec Ltd.]
ActivaNailTM Conical2008-06-26
BIORETEC LTD
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM2008-06-24
BIORETEC LTD
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN2008-06-18
Michael van der Woude [Bioretec Ltd.]
K-wires (10 pcs) for 2.0mm RFS? Pin2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?3.2 mm, length 130 mm, for 3.2 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?2.8 mm, lenght 130 mm, for 2.7 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?2.0 mm, length 260 mm, arthroscopic, for 2.0 mm pins/nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?2.0 mm, length 130 mm, stepped shaft, for 2.0 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?2.0 mm, length 130 mm, for 2.0 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 260 mm, cone tip, arthroscopic, for 1.5 mm pins/nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 260 mm, arthroscopic, for 1.5 mm pins/nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 150 mm, trocar tip, for 4.0/4.5mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 150 mm, threaded tip, for 4.0/4.5mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.25 mm, length 150 mm, trocar tip, for 3.5mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.25 mm, length 150 mm, threaded tip, for 3.5mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire 1.6x300mm trocar with measuring ring at 150mm2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire 1.5 mm, length 260 mm, for 1.5 mm pins/nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire 1.5 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.2008-01-02
Michael van der Woude [Bioretec Ltd.]
Bioretec surgical instrument2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator with K-wire ?3.2 mm, disposable,for 3.2 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator with K-wire ?2.8 mm, disposable, for 2.7 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator with K-wire ?2.0 mm, disposable,for 2.0 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator with K-wire ?1.6 mm, disposable, for 1.5mm ActivaPin? Fusion2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator with K-wire ?1.6 mm, disposable, for 1.5 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator tip, arthroscopic, for 2.0 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator tip, arthroscopic, for 1.5/2.0 mm nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator tip, arthroscopic, for 1.5 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator housing, arthroscopic, for pins and nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator handle, arthroscopic, for pins and nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator ?3.2 mm, reusable, for 3.2 mm pins and for 1.5/2.0/2.7/3.2 mm nails2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator ?2.0 mm, reusable, for 2.0 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Applicator ?1.5 mm, reusable, for 1.5 mm pins2008-01-02
Michael van der Woude [Bioretec Ltd.]
Torx shaft for 4/5/6 mm interference screw with quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Torx driver, for 7/8/9/10 mm interference screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Torx shaft for 4/5/6 mm interference screw with quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Torx driver, for 7/8/9/10 mm interference screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Notcher for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Large handle, cannulated, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc K-wire 1.6 mm, length 300 mm, blunt ends, for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc K-wire 1.6 mm, length 240 mm, blunt ends, for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc K-wire 0.8 mm, length 300 mm, blunt ends, for 4/5/6 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc K-wire 0.8 mm, length 150 mm, blunt ends, for 4/5/6mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Drill bit 5.0 mm, cannulated, for 5 mm interference screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
TorqLoc Drill bit 4.0 mm, cannulated, for 4 mm interference screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?4.5 mm, for 4.5 mm screws up to length 90 mm2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?4.5 mm, for 4.5 mm screws up to length 45 mm2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?4.5 mm, for 4.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?4.0 mm, for 4.0 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?3.5 mm, for 3.5 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?3.5 mm, for 3.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?2.7 mm, for 2.7 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Tap ?2.0 mm, for 2.0 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
T-handle, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Sterilization tray, for ActivaScrew? instruments2008-01-02
Michael van der Woude [Bioretec Ltd.]
Sterilization tray, for ActivaScrew? Interference instruments2008-01-02
Michael van der Woude [Bioretec Ltd.]
Sterilization tray, for ActivaScrew? Cannulated instruments2008-01-02
Michael van der Woude [Bioretec Ltd.]
Sterilisation tray, for ActivaPin? instruments2008-01-02
Michael van der Woude [Bioretec Ltd.]
Small handle, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Screw holding sleeve for 2.0/2.7/cannulated 3.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Protection sheath2008-01-02
Michael van der Woude [Bioretec Ltd.]
Notcher for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
Large handle, cannulated, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 240 mm,? for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?1.6 mm, length 240 mm, blunt ends, for 7/8/9/10 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?0.8 mm, length 150 mm, for 4/ 5/6 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire ?0.8 mm, length 150 mm, blunt ends,? for 4/ 5/6 mm interference screw2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire 1.6 mm, length 300 mm, for 7, 8, 9 or 10 mm interference screw, blunt ends2008-01-02
Michael van der Woude [Bioretec Ltd.]
K-wire 0.8 mm, length 300 mm, for 4, 5 or 6 mm interference screw, blunt ends2008-01-02
Michael van der Woude [Bioretec Ltd.]
Instrument set, for ActivaPin2008-01-02
Michael van der Woude [Bioretec Ltd.]
Holding sleeve, for 4.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Holding sleeve, for 4.0/4.5mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Holding sleeve, for 2.0/2.7/3.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
HEX shaft, for 4.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
HEX shaft, for 4.0/4.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
HEX shaft, for 3.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
HEX shaft, for 2.0/2.7/3.5 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?6.0 mm, cannulated, for 6 mm interference screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?5.0 mm, cannulated, for 5 mm interference screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?4.0 mm, cannulated, for 4 mm interference screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?3.5 mm, for 4.5 mm cannulated screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?3.2 mm, for 4.5 mm screws up to length 90 mm, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?3.2 mm, for 4.0 mm cannulated screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?2.7 mm, for 3.5 mm cannulated screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?2.7 mm, for 2.7 mm pins/nails, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?2.5mm, for 3.5 mm screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?2.0 mm, for 2.7 mm screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?2.0 mm, for 2.0 mm pins/nails, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?1.5 mm, for 2.0 mm screws, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit ?1.5 mm, for 1.5 mm pins/nails, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit 3.2 mm, for 4.5 mm screws up to length 70 mm, quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Drill bit 3.2 mm, for 3.2 mm pins/nails, with quick coupling2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?4.5/3.5 mm, for 4.0/4.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?3.2/4.5 mm, for 4.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?2.7/3.5 mm, for 3.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?2.5/3.5 mm, for 3.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?2.0/2.7 mm, for 2.7mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Double drill sleeve ?1.5/2.0 mm, for 2.0mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Direct driver, for 4.0/4.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Direct driver, for 3.5 mm cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Countersink, for cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Countersink, for 4.5mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Countersink, for 2.7/3.5 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Countersink, for 2.0 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
ActivaScrew? Interference Instrument Set2008-01-02
Michael van der Woude [Bioretec Ltd.]
ActivaScrew? Instrument Set2008-01-02
Michael van der Woude [Bioretec Ltd.]
ActivaScrew? Instrument Set (without 2mm)2008-01-02
Michael van der Woude [Bioretec Ltd.]
ActivaScrew? Cannulated Instrument Set2008-01-02
Michael van der Woude [Bioretec Ltd.]
3.5mm HEX driver2008-01-02
Michael van der Woude [Bioretec Ltd.]
2.5mm HEX driver2008-01-02
Michael van der Woude [Bioretec Ltd.]
Depth gauge, for cannulated screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Depth gauge, for 4.5 mm screws2008-01-02
Michael van der Woude [Bioretec Ltd.]
Depth gauge, for 2.0/2.7/3.5 mm screws2008-01-02
BIORETEC LTD
ACTIVASCREW2007-11-02
BIORETEC LTD
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)2007-08-31
BIORETEC LTD
ACTIVASCREW2006-11-22
BIORETEC LTD
ACTIVAPIN2006-07-06

Related Finance Registrations
SEC0001532629Bioretec Ltd of FINLAND
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